NCT02476552

Absorption, Metabolism, Excretion, and the Determination of Absolute Bioavailability of Niraparib in Subjects With Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Tesaro, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label study with 2 parts, plus an extension study following completion of Parts 1 or 2, that is being conducted in approximately 12 subjects (6 subjects in Part 1; 6 subjects in Part 2) with cancer to examine the absorption, metabolism, excretion, and absolute bioavailability of niraparib.

Detailed description

Part 1: After an overnight fast of at least 10 hours, subjects will receive a single, oral dose of niraparib (unlabeled active pharmaceutical ingredient) on Day 1. Two hours after the oral dose, subjects will receive a 15-minute IV infusion of niraparib (labeled pharmaceutical ingredient). Part 2: After an overnight fast of at least 10 hours, subjects will receive a single, oral dose of niraparib, labeled active pharmaceutical ingredient.

Conditions

• Cancer

Interventions

Type	Name	Description
DRUG	Niraparib Oral Capsules (Labeled)	Single 300 mg dose of niraparib
DRUG	Niraparib IV (Labeled)	Intravenous (IV) infusion of 100 μg niraparib (containing approximately 1 μCi of \[14C\]-niraparib)
DRUG	Niraparib Oral Capsules (Unlabeled)	Single 300 mg dose of niraparib (unlabeled active pharmaceutical ingredient)

Timeline

• Start date: 2015-02-01
• Primary completion: 2015-12-01
• Completion: 2018-01-01
• First posted: 2015-06-19
• Last updated: 2020-01-13

Locations

1 site across 1 country: Netherlands